Treatment of Dry Eye Disease Using Pro-ocular™ - A Proof of Concept, Safety, and Efficacy Study

NCT04884217 | Unknown Phase 2 FDA Drug

• 1 other identifier: DE-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of 1% Pro-ocular topical gel administered twice daily for 12 weeks in treatment of Dry Eye Disease

Conditions

Dry Eye Syndrome; Keratoconjunctivitis Sicca

Keywords

Dry Eye; Dry Eye Disease; Evaporative Dry Eye; Evaporative Dry Eye Disease; Keratoconjuncitivitis Sicca; Sjogren's Sydrome

Outcome Measures

Primary Outcomes (2)

• Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

  Change from baseline in SANDE symptoms frequency score (0-100 worst)

  2 weeks

• Change in corneal (central) fluorescein staining score

  Change from baseline in score on a visual analog scale (0-10 worst)

  4 weeks

Secondary Outcomes (77)

• Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

  2 weeks

• Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

  4 weeks

• Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

  8 weeks

• Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Global score

  12 weeks

• Change in SANDE (Symptom Assessment iN Dry Eye) Questionnaire Frequency score

  4 weeks

Study Arms (2)

Pro-ocular™

ACTIVE COMPARATOR

Pro-ocular™ Topical Gel

Drug: Pro-ocular™ Topical Gel

Placebo

PLACEBO COMPARATOR

Placebo Topical Gel

Drug: Placebo Topical Gel

Interventions

Pro-ocular™ Topical Gel DRUG

Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily

Also known as: PG101

Pro-ocular™

Placebo Topical Gel DRUG

Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of any race, at least 20 years of age at Visit 1 Screening.
• Has a subject reported history (including physician diagnosis) of dry eye disease in both eyes for at least 3 months prior to Visit 1.
• Has SANDE score ≥50 in either frequency or severity of symptoms of dryness and/or irritation at Visit 1.
• Have all of the following in the same eye at Visit 1:
• Fluorescein Tear Break-Up Time of ≤5 seconds.
• Corneal fluorescein staining score of moderate or more in any field (inferior, superior or central).
• Report a severity score of moderate or more on ocular dryness and at least one of the other symptoms on the GLIA Ocular Surface Disease Symptoms Questionnaire.
• Has provided written informed consent.
• Be able and willing to follow oral and written instructions, including participation in all study assessments and visits.

You may not qualify if:

• Comorbidity with other severe or chronic eye conditions that in the judgment of the investigator will interfere with study assessments, such as but not limited to corneal opacities and scars, dystrophies, epithelial scarring, infections, history of blood clots, etc.
• Has infections, or inflammatory skin lesion in or around the dosing area.
• Best corrected visual acuity baseline \<20/200.
• Has a condition or history that, in the opinion of the investigator, may interfere significantly with the subject's participation in the study.
• Wear contact lens within 7 days prior to Visit 1.
• Anticipate change of vision correction or anticipate any ocular procedures during study period.
• A woman who is pregnant or testing positive in the blood pregnancy test at screening, nursing an infant, or planning a pregnancy.
• Has a known adverse reaction and/or sensitivity to the study drug or its components.
• Use of topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs within 30 days prior to Visit 1.
• Routine use (more than once a week) of a chlorinated swimming pool during study period.
• Unwilling or unable to cease using the following medications during the study period (from Visit 1 to Visit 6): Topical ocular cyclosporine (e.g. Restasis®), lifitegrast (Xiidra®), diquafosol (Diquas®), eye gels, eye ointments, any administration route of steroids, anti-histamines, antipsychotics, antidepressants and NSAIDs..
• Unwilling to cease the use of sunscreen and face scrubs on the forehead or eye area during study period.
• Smoke within 3 months prior to Visit 1.
• Ongoing glaucoma treatment within 30 days prior to Visit 1 and during study period.
• Currently enrolled in an investigational drug or device study within 30 days prior to Visit 1 and during study period.

Sponsors & Collaborators

• PharmaDax Inc.: lead
• Glia, LLC: collaborator

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 11490, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Study Officials

• Peichun Kuo

  PharmaDax Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 12, 2021
• Study Start: May 20, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)